In many cases, drugs which are available in a market cause side effects which could not be found by inspection upon development. Hence, doing researches to quickly find side effects which occur in the market and managing side effect information are important to manage safety of drugs and improve the drugs.
Currently, when a drug causes a side effect, each medical organization needs to report the side effect to, for example, a government. When a side effect is reported, this information is accumulated in a side effect report database (side effect DB). It is difficult for people to check and process all reports on side effects accumulated in the side effect DB, and therefore methods of specifying a side effect of a drug from these reports are being proposed.
Non Patent Literature 1 discloses a method of detecting a pair of a drug and a side effect by using methods such as Bayesian Confidence Propagation Neural Network, Gamma-Poisson Shrinker and Reporting Odds Ratio. According to the method disclosed in Non Patent Literature 1, information including a pair of “drug-side effect” is automatically extracted from the side effect DB in which an enormous amount of information is stored, and a side effect of a drug is detected based on the event probability of this pair.
Further, Patent Literature 1 discloses a clinical trial managing system which comprehensively manages clinical trials. The system disclosed in Patent Literature 1 has a set exclusion criterion indicating, for example, an abnormal value of data or occurrence of a side effect. Further, whether or not a side effect occurs is decided based on whether or not an abnormal value is produced or a doctor's opinion.
Furthermore, Patent Literature 2 discloses a method of identifying and predicting a drug side effect. According to the method disclosed in Patent Literature 2, an ADE (Adverse Drug Events) rule is defined in advance. Further, when a test value is not included in a range of a normal test value in the ADE rule, the test value is decided to be abnormal and warning processing is performed.